Apr 16, 2024  
2015-2016 Undergraduate Academic Catalog 
2015-2016 Undergraduate Academic Catalog [ARCHIVED CATALOG]

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BE 3000 - Biomedical Engineering Design II

1 lecture hours 2 lab hours 2 credits
Course Description
This course continues the biomedical engineering (BE) design sequence started in the last quarter of the sophomore year. Covered in this course are topics essential for the Progress and Feasibility presentation, which typically takes place in week two of the winter quarter. Coverage of FDA regulatory requirements is continued with a discussion of device classification. The ethical context of experimentation involving human and non-human animal subjects is discussion along with associated federal regulation and institutional policies. Practical design techniques and tools - such as creative problem solving methods, 3-D CAD software, technical graphics, project management and feasibility evaluation methods - are explained. (prereq: BE 2000 )
Course Learning Outcomes
Upon successful completion of this course, the student will be able to:
  • Apply one or more creative problem solving techniques to their project
  • Prepare meaningful technical graphics related to their project
  • Evaluate the competitive environment and market for their proposed product
  • Evaluate the technical and economic feasibility of their project
  • Be prepared for their junior Progress and Feasibility presentation
  • Identify the FDA Device Class of their product and understand the implications of this classification
  • Use project management techniques and software to plan and manage their project
  • Discuss the ethical and regulatory issues involved in experiments using of human and non-human animal subjects

Prerequisites by Topic
  • An overall understanding of the design process, both in general and for the MSOE BME program
  • The role of the FDA in medical device regulation
  • Design documentation requirements

Course Topics
  • Market & Competitive Analyses
  • Codes & Standards
  • Creative Problem Solving
  • CAD and Solid Modeling
  • Technical Graphics
  • Project Management & Scheduling
  • Feasibility Evaluation
  • Animal & Human Experimental Subject Ethical and Regulatory Issues

Laboratory Topics
  • Team and individual project activities
  • 3-D CAD and Solid Modeling

Charles Tritt

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